Actively Recruiting
Platelet Rich Fibrin Combined With Topical Antibiotics or Antiseptics for Chronic Wounds Treatment in a Randomized, Active Controlled, Double-Blind Trial
Led by Medical University of Vienna · Updated on 2022-04-07
120
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of platelet rich fibrin (PRF) combined with topical antibiotics or antiseptics for treating infected chronic wounds. This randomized controlled trial compares three different PRF treatments to an active silver gauze wound dressing, aiming to provide evidence on how PRF works alone and when mixed with antimicrobial compounds. The study focuses on patients with infected chronic venous ulcers and excludes those with certain severe conditions or untreated diabetes. The trial has four treatment groups: PRF mixed with amikacin and teicoplanin sprayed onto the wound, PRF with placebo saline spray, PRF combined with polyhexanide and macrogolol spray, and a silver gauze dressing as the control. Participants receive treatment for 56 days, with wound surface area measured at baseline, day 28, and day 56. Infection parameters such as C-reactive protein and leukocyte counts are monitored weekly, and systemic antimicrobial therapy is started if needed based on specialist evaluation. Participants will visit regularly for wound assessments, blood tests, and monitoring of infection signs. Researchers will evaluate wound area reduction after 56 days as the primary outcome, along with secondary outcomes including the need for systemic antibiotics, time to wound sterility, and presence of drug-resistant bacteria. The study includes close monitoring of infection status and safety measures throughout the treatment period.
CONDITIONS
Brief Title
PRF With Topical Antibiotics or Antiseptics in Chronical Wounds Version 1.4
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged over 18 who can give informed consent
- Chronic venous ulcer with localized non-systemic soft-tissue infection diagnosed by a senior infectious diseases specialist
- Wound size of at least 5 cm2 and less than 200 cm2
You will not qualify if you...
- Untreated diabetes mellitus with HbA1c greater than 12 mg/dl
- Untreated diabetic foot syndrome without appropriate treatment
- Peripheral vascular disease with ankle brachial index less than 0.7
- Wound size less than 15 cm2 or greater than 200 cm2
- C-reactive protein greater than 5 mg/dl
- Leukocyte count greater than 15,000 per microliter
- Infection at another site
- Ulcer infection with pathogens resistant to amikacin and teicoplanin
- Known osteomyelitis, erysipelas, or phlegmon
- Complicated deep tissue infections not treatable with PRF plus antimicrobial therapy
- Planned systemic antimicrobial therapy
- Active viral hepatitis (A, B, or C), active HIV infection, or active syphilis
- Increased sensitivity to amikacin, teicoplanin, PHMB, macrogolol, tramexanic acid, or batroxobin
- Presence of neoplastic growth in the ulcer
- Thrombocytopenia (platelet count less than 150,000 G/L)
- Hemoglobin less than 95 g/L
- Known pregnancy or lactation
- Severe renal impairment (creatinine clearance less than 30 ml/min)
- History or signs of cochlea or vestibular system impairment
- Neuromuscular diseases such as Myasthenia gravis or Parkinson's disease
- Aminoglycoside treatment within four weeks before inclusion
- Other reasons determined by investigators opposing study participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive one of the study treatments applied to their chronic ulcer: PRF mixed with amikacin and teicoplanin, PRF mixed with PHMB plus Macrogolol, PRF plus normal saline, or silver gauze (Acticoat 7).
Visits on days 0, 7, 14, 21, 28, 35, 42, 49, and 56 for treatment and assessments
Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1190
Actively Recruiting
Research Team
F
Florian Thalhammer, Prof. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Frequently Asked Questions
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